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FDA Draft Enforcement Policy for Certain IVDs: Specific Aspects
The new article highlights certain specific aspects pertaining to the regulatory framework, emphasizing the key points to be taken into consideration.
The new article highlights certain specific aspects pertaining to the regulatory framework, emphasizing the key points to be taken into consideration.
The US Food and Drug Administration (FDA), the authority responsible for medical device regulation, issued guidance intended to assist the manufacturers of In Vitro Diagnostic Devices (IVD) in filing applications for the CLIA Waiver. CLIA Waiver: The Scope of...
The difference between CLIA and FDA standards